Device product
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
Z-0444-2019
Product summary
- Event
- Event 81003
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230 units
- Official record key
device-enforcement:Z-0444-2019
Official wording
Reason: Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
Code information: Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08
Distribution pattern: US Nationwide in the states of CA, IL, MT, NC, NJ,
Derived failure modes
-
Labeling or packaging
Label was incorrect